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TSG warning to hearing healthcare professionals
i
A hearing healthcare professional should advise a prospective sound generator user to consult promptly
with a licensed physician (preferably an ear specialist) before getting a sound generator if the hearing
healthcare professional determines through inquiry, actual observation, or review of any other available
information concerning the prospective user that the prospective user has any of the following conditions:
(i) Visible congenital or traumatic deformity of the ear.
(ii) History of active drainage from the ear within the previous 90 days.
(iii) History of sudden or rapidly progressive hearing loss within the previous 90 days.
(iv) Acute or chronic dizziness.
(v) Unilateral hearing loss of sudden or recent onset within the previous 90 days.
(vi) Audiometric air-bone gap equal to or greater than 15dB at 500 hertz (Hz), 1000 Hz, and 2000 Hz.
(vii) Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
(viii) Pain or discomfort in the ear.
General Precautions
i
• Wearing an instrument might cause an increased production of earwax. In rare cases, the anti-allergenic
materials may cause skin irritation. If so, or if in doubt, consult your physician or ENT
• For use of wireless functionality, only use Beltone Direct Line accessories. For further guidance, please
refer to the relevant Beltone Direct user guide.
• Only connect Beltone hearing instruments to Beltone accessories intended and qualified to be used with
Beltone hearing instruments.
• When wireless function is activated, the device uses low-powered, digitally coded transmissions in
order to communicate with other wireless devices. Although unlikely, nearby electronic devices may be
affected. In that case, move the hearing instrument away from the affected electronic device.
• When using wireless functionality and the devices are affected by electromagnetic interference, move
away from the source interference.
• Use only original Beltone consumables e.g. wax guards.
• Never attempt to modify the shape of the hearing instrument, earmoulds, or tubing yourself.